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Fibrinogen and LDL Apheresis in Treatment of Sudden Hearing Loss: A Randomized
Multicentre Trial
The Lancet
2002;360:1811-1817.
M Suckfüll, for the Hearing Loss Study Group
The causes of sudden sensorineural hearing loss (SSHL) are unclear but are believed
to include changes in microcirculation, autoimmune pathology, or viral infection.
The identification of various circulatory disturbances in some individuals suffering
from SSHL supports the role of vascular pathogenesis in this condition. A pilot
study of SSHL in patients with hyperfibrinogenemia or hypercholesterolemia found
that LDL-apheresis was more successful in restoring hearing than was the standard
therapy with steroids, dextrane, and pentoxifylline.* It is suggested
that the decreased levels of plasma fibrinogen and the increased release of nitric
oxide due to reduced serum cholesterol following LDL-apheresis result in improved
blood flow.
The present study investigated whether a single fibrinogen/LDL-apheresis treatment
was equally or more effective than a standard treatment of prednisolone, hydroxyethyl
starch, and pentoxifylline in treating SSHL. A total of 201 patients were enrolled,
of which 134 were randomly assigned to the apheresis group and 67 to the standard-treatment
group. The primary outcome was recovery of hearing as measured by pure-tone audiometry
48 hours following the start of treatment and was assessed in 111 (83%) apheresis-group
patients and in 59 (88%) standard-group patients. Secondary outcomes were the recovery
of hearing 6 weeks posttreatment, improvement of speech audiometry, tinnitus, and
frequency of side effects. Secondary outcomes were assessed for 109 and 54 patients
in the apheresis and standard groups, respectively.
Hearing improved in both groups at 48 hours and 6 weeks posttreatment, but with
no significant differences between the groups. In contrast, a significant difference
(P=0.034) in mean speech perception was evident 48 hours posttreatment
in the apheresis group (21.6 ± 20.8 decibels [dB]) compared with the standard
group (29.3 ± 29.4 dB). This difference was still detectable at 6 weeks (13.7
± 14.3 dB vs 20.8 ± 25.4 dB, P= 0.059) but was not deemed
significant.
Subgroup analysis demonstrated that patients with median plasma fibrinogen concentrations
above 8.68 µmol/L showed greater improvement in speech perception following
apheresis (15.3 ± 2.5 dB) compared with treatment by standard means (6.1
± 2.0 dB, P=0.005). Similar findings were seen in patients with
LDL-C levels above 3.47 mmol/L (11.2 ± 1.7 dB vs 4.6 ± 1.6 dB).
The authors conclude that a single fibrinogen/LDL-apheresis treatment can be used
as an alternative to conventional treatments with infusions and steroids for 10
days.
Click for full abstract.
* See also: Suckfüll M, Thiery J, Schorn K, Kastenbauer E,
Seidel D. Clinical utility of LDL-apheresis in the treatment of sudden hearing loss:
a prospective randomized study. Acta Otolaryngol. 1999;119:763-766.
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